Drug discovery is a sophisticated process involving the use of cutting-edge technologies and advanced scientific methods. It is a highly resource-intensive and expensive process. Amongst the different types of available drugs, the discovery and development of biological therapies has gained substantial impetus in the past few years. In the past decade, the focus of majority of pharmaceutical companies has shifted towards the discovery and development of biologics, particularly monoclonal antibodies. This shift in focus is evident from the fact that more than five novel monoclonal antibodies (composing 20% of total novel drugs) have been approved annually by the FDA in the last three years. Moreover, the recent years have witnessed many companies / organizations with elaborate portfolios, covering antigen design and characterization to development and selection of viable pharmacological leads.
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Although the currently used approaches for discovering antibody-based therapeutics are effective in their own ways, a number of players in this domain are directing their efforts towards the development of new ways to expedite the discovery and isolation processes for antibody-based therapies. The basic process for the discovery of therapeutic antibodies is somewhat similar to that of small molecule drugs and can be divided into six major steps.
There are several methods available for the discovery of antibodies, specifically, monoclonal antibodies. In addition, there is a lot of ongoing effort for development of advanced techniques to reduce the immunogenic potential, modify potency and safety, and to increase the rate of production of antibodies. The antibody discovery methods primarily comprise of:
§ Hybridoma
§ In vitro display technologies (library-based display methods)
§ Phage display
§ Yeast display
§ Ribosomal display
§ Transgenic animal based-methods
§ Single human B cell cloning techniques
|
S. No. |
Method |
Advantages |
Disadvantages |
|
1 |
Hybridoma |
§ Well established technology § Cost effective § Easy to use |
§ Risk of high immunogenicity § Species restriction due to the requirement of myeloma cells |
|
2 |
Phage Display |
§ Well established technology § Simple selection methods § Can be used for complex antigens |
§ The efficiency of DNA transformation into bacteria has always been the limiting step for constructing large libraries § Not all antibodies are well expressed in Escherichia coli and require further processing (post translational modifications) |
|
3 |
Yeast Display |
§ Eukaryotic system, therefore, doesn’t require additional post-translational modifications to be carried out post production § Rapid selection of improved affinity variant is possible |
§ Relatively small library size § Not suitable for complex antigens |
|
4 |
Mammalian Display |
§ Relatively fast method § Human sequences; no immunogenicity § Amenable to selection by FACS |
§ Increased off-target binding § Low efficiency of transformation / transfection |
|
5 |
Ribosomal Display |
§ Large library size (1011) possible § Mutagenesis can be introduced in between PCR rounds |
§ Comparatively low stability of mRNA § Not suitable for complex antigens |
|
6 |
Transgenic Animals |
§ Capable of generating high affinity, fully human antibodies § Efficient production of large and diverse lead panels |
§ Technology inaccessibility; most are not available for in-licensing § Robust screening methods required for isolation of desirable leads |
|
7 |
Single B cell Technology |
§ Requires relatively less number of cells § No fusion step required § Human sequences; no immunogenic response |
§ Obtaining antibodies with good affinity for all targets is a challenge |
Antibody based pharmacological interventions represent the largest and fastest growing biologic product class. It is worth mentioning that antibodies also form the basis of a certain cell therapies as well, and are also used for diagnostic purposes. Amidst the COVID-19 pandemic, these molecules have been extensively used in diagnostic tests. Moreover, multiple research groups are currently engaged in efforts to develop antibody-based therapeutics / vaccines against the novel coronavirus. Further, there are several emerging antibody formats, such as bispecific antibodies, antibody drug conjugates, and antibody fragments, which are gradually gaining widespread attention among drug / therapy developers. Given the growing demand for antibodies, the role of contract service providers offering biologic development and manufacturing expertise has become indispensable. Moreover, the recent years have witnessed establishment of a number of contract research organizations (CROs) and contract manufacturing organizations (CMOs) specializing in antibody discovery / development. Outsourcing is considered to be a favorable approach in this field, allowing innovator companies to focus on initial R&D and marketing, while the more seasoned experts at CROs / CMOs handle product development and production responsibilities.
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